Radiofrequency Non-ablative in the Treatment of Genitourinary Syndrome of Menopause

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study is conducted in women at the menopause with a clinical diagnosis of Genitourinary Syndrome, which presents symptoms in of vulvovaginal atrophy and tract urinary and were treated with radiofrequency non ablative technique for capacitive transfer in intra-vaginal. All participants were evaluated by a physical therapist and did the exam of PH vaginal, cell maturation index and questionnaires. The participants made five sessions of Radio Frequency (RF) with an interval of seven days between them. The application of RF was performed by physical therapist trained in the technique of radio frequency through the Capenergie brand device with capacitive transfer method using non-ablative handle with active electrode intra-vaginal and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration above 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes in the anterior wall and 2 minutes more in the posterior wall of vagina.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 45
Maximum Age: 65
Healthy Volunteers: f
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• will be women in menopause until 65 years of age with clinical complaints of Genitourinary Syndrome of Menopause and who agree to voluntarily participate in the research.

Locations
Other Locations
Brazil
Centro de Atenção ao Assoalho Pelvico
RECRUITING
Salvador
Time Frame
Start Date: 2018-04-01
Estimated Completion Date: 2026-06-20
Participants
Target number of participants: 58
Treatments
Active_comparator: Radiofrequency ON and Kinesiotherapy
The radiofrequency application protocol with the CAPENERGY device, which has two electrodes: an active one, which will be introduced into the vagina, using a condom and gel to the emission of radiofrequency and another electrode, dispersive, coupled to the patient's hip, which will function as earth. The temperature used in the treatment will be 41°C, which this parameter will be placed in the equipment, maintained for 2 minutes at the anterior wall and 2 others minutes at the posterior wall. Five RF sessions will be performed, with a seven-day interval between them. For the application, participants will be placed in supine position. The session will be quick, with an average duration of 20 minutes. Kinesiotherapy will be done once a week, totaling five sessions. Initially, verbal information about location, function, and the correct way to contract the pelvic floor (PA) will be given.
Placebo_comparator: Radiofrequency OFF and Kinesiotherapy
The patient will be in supine decubitus, the vaginal probe of the radiofrequency apparatus will be introduced, with the gel previously heated. The radiofrequency will be off.~Kinesiotherapy will be done once a week, totaling five sessions. Initially, verbal information about location, function, and the correct way to contract the pelvic floor (PA) will be given.
Related Therapeutic Areas
Sponsors
Leads: Centro de Atenção ao Assoalho Pélvico

This content was sourced from clinicaltrials.gov

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